MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT ANTI-N (MNS2); SERACLONE ANTI-N (MNS2)

Catalog Number	808415100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported a mistyping with seraclone anti-n.The customer was not able to provide a date of event.She also did not provide any information, whether a false negative or a false positive result was obtained.The customer returned the supposedly defective product for investigational testing and a panel cell of a competitor, but did not yet provide the requested information.Our quality control laboratory is still waiting for the information about the complaint cause to start testing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported a mistyping with seraclone anti-n by using panocell #1 (the donor cell is identified as mn) from immucor (lot # 45028).Customer informed us that false negative results were obtained.The customer returned the supposedly defective product and also the competitor's product panocell #1 at the time the material arrived on our premises, the panocell was already expired.Our quality control laboratory tested the titer of the allegedly defective sample seraclone anti-n in parallel to their retained product sample and also against a reference lot.The minimum titer was reached and all other reagents showed comparable titer and reaction strength.Panocell #1 was tested with three monoclonal anti-n reagents and showed +/- reactions.Testing with polyclonal anti-n showed 3w positive results.The allegedly defective material, the retained sample and a reference lot was tested with positive reagent red blood cells (biotestcell, immucor).The reactions were clearly positive (4+).Testing by our quality control laboratory confirmed the correct functionality of the allegedly defective lot of seraclone anti-n.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: BLOOD GROUPING REAGENT ANTI-N (MNS2)
• Common Device Name: SERACLONE ANTI-N (MNS2)
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 6249596
• Report Number: 9610824-2016-00100
• Device Sequence Number: 18854263
• Product Code: KSZ
• UDI-Device Identifier: 07611969952052
• UDI-Public: 07611969952052
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2017
• Device Catalogue Number: 808415100
• Device Lot Number: 8508130-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/22/2016
• Supplement Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1